Efficacy and safety of inhaled nitrite in addition to sildenafil in thalassemia patients with pulmonary hypertension: A 12-week randomized, double-blind placebo-controlled clinical trial.

Pulmonary hypertension is a significant complication in thalassemia patients. Recent studies showed that inhaled nebulized nitrite could rapidly decrease pulmonary artery pressure. We conducted a multicenter, randomized, double-blind, placebo-controlled trial in thalassemia patients with symptomatic pulmonary hypertension diagnosed by right heart catheterization. Eleven patients were recruited; five were assigned to the nitrite group and six to the placebo group. Patients were treated with the optimal doses of sildenafil for pulmonary hypertension and randomly assigned into the placebo or nitrite groups. Patients in the nitrite group were given inhaled nebulized 30 mg sodium nitrite twice a day for 12 weeks. The clinical outcomes measured at week 12 were the changes in 6-min walk distance (6MWD), mean pulmonary artery pressure (MPAP), and N-terminal pro B-type natriuretic peptide. The MPAP estimated by echocardiography was significantly reduced from 33.6 ± 7.5 mmHg to 25.8 ± 6.0 mmHg (mean difference = 7.76 ± 3.69 mmHg, p = 0.009 by paired t-test). Furthermore, 6MWD was slightly increased from 382.0 ± 54.0 m to 432 ± 53.9 m (mean difference = 50.0 ± 42.8 m, p = 0.059 by paired t-test) in the nitrite group. At week 12, the nitrite group had lower MPAP than the placebo group (25.8 ± 6.0 vs. 45.7 ± 18.5 mmHg, p = 0.048 by unpaired t-test). No significant difference in 6MWD and N-terminal pro B-type natriuretic peptide between the two groups was observed at week 12. There was no hypotension or other significant adverse effects in the nitrite group.

Transcatheter tricuspid valve-in-valve implantation for degenerative surgical bio-prosthesis using SAPIEN 3: A case series.

We evaluated early outcomes of transcatheter valve-in-valve (ViV) implantation in patients with degenerated bio-prosthesis in tricuspid position. Total of 5 patients were included in our case series. Baseline native tricuspid valve etiology were highly varied ranging from chest wall trauma, Ebstein anomaly, rheumatic heart disease, infective endocarditis and complex congenital heart disease. These differences also made patient comorbidities highly varied. Procedure details were also varied due to different clinical and technical challenges. All cases underwent successful Tricuspid VIV implantation with satisfactory hemodynamics results. All patients experienced improved clinical symptoms at follow up.

Inhaled nebulized sodium nitrite decreases pulmonary artery pressure in ß-thalassemia patients with pulmonary hypertension.

Pulmonary hypertension is a life-threatening complication in ß-thalassemia. Inhaled sodium nitrite has vasodilatory effect on pulmonary vasculature. However, its effect on pulmonary artery pressure (PAP) in ß-thalassemia subjects with pulmonary hypertension has never been reported. In this study, we investigated the change in PAP during inhalation of sodium nitrite in 5 ß-thalassemia patients. We demonstrated that sodium nitrite administered by nebulization rapidly decreased PAP as measured by echocardiography and right heart catheterization. The effect of nitrite was short as PAP returned to baseline at end of inhalation. Our findings support acute pulmonary vasodilation effect of nitrite in ß-thalassemia with pulmonary hypertension.

A clinical evaluation of the XIENCE V everolimus eluting stent in the treatment of patients with coronary artery disease: Result from Thailand Registry - XIENCE V performance evaluation (THRIVE study).

OBJECTIVE: To evaluate the 2-year clinical outcomes of XIENCETM V everolimus eluting stent (EES) for the treatment of coronary artery disease. BACKGROUND: Percutaneous coronary intervention with a drug eluting stent has become the preferred treatment in patients with coronary artery disease. Everolimus eluting stent had proven efficacy in randomized control trials but those trials may not represent daily practice of interventional cardiology. METHODS: The THRIVE study was a prospective, multicenter, real-world, single-arm registry. Included in the registry were 400 patients in Thailand with coronary artery disease suitable for treatment with the XIENCETM V. RESULTS: At 30 days, 1 year, and 2 years, the respective rate of all-cause mortality, myocardial infarction (MI), and target lesion revascularization (TLR) was 0.7, 1.0, and 0.5 %. 2.1, 2.1, and 1.0 %, and 2.2, 3.0, and 2.1 %. The cumulative rate for stent thrombosis was 1.6 % at 2 years. CONCLUSIONS: The THRIVE study demonstrated that use of EES yielded a rate for 2 years of major adverse cardiac events comparable to the randomized controlled trial of EES in the SPIRIT trials. This result supports the efficacy and safety of XIENCETM V everolimus eluting for daily interventional cardiology practice.

Transcoronary bone marrow-derived progenitor cells in a child with myocardial infarction: first pediatric experience.

BACKGROUND: Recent advances in stem cell therapy to restore cardiac function have great promise for patients with congestive heart failure after myocardial infarction in an adult population. OBJECTIVE: We examined the benefits of bone marrow-derived progenitor cells treatment modality for the pediatric patient. METHODS AND RESULTS: We present our first case of transcoronary autologous stem cell transplantation in a 9-year-old girl with refractory congestive heart failure secondary to myocardial infarction 1 year after transcatheter revascularization. The child received daily injections of granulocyte colony-stimulating factor for 3 days prior to the bone marrow aspiration. The bone marrow cells were isolated to constitute CD133+/CD34+ more than 90% of the total number. Subsequently, the progenitor cell suspension was injected via a transcoronary catheter without any complication. Three months after stem cell therapy, her cardiac function, assessed by both cardiac magnetic resonance and echocardiogram, has been improved with the left ventricular ejection fraction at 47% compared to the baseline of 30%. CONCLUSION: This is the first reported pediatric case of successful transcoronary injection of bone marrow-derived progenitor cells for end-stage heart disease. The procedure is considered safe and feasible for the pediatric population.

Transcoronary infusion of bone marrow derived multipotent stem cells to preserve left ventricular geometry and function after myocardial infarction.

BACKGROUND: Myocardial damage after myocardial infarction (MI) was deemed irreversible after late reperfusion. Administration of multipotent stem cell (MSC) into such infarct may regenerate the myocardium and capillary network. HYPOTHESIS: Transcoronary infusion of bone marrow derived multipotent stem cells into infarcted related artery after acute myocardial infarction is feasible, safe and improve left ventricular function. METHODS: We conducted a pilot study in patients who survived ST-elevation MI with late reperfusion therapy and remained hemodynamically stable. Bone marrow derived MSC was infused into a patent infarct-related coronary artery during brief low pressure (2 atm) balloon inflation. A 3-T gadolinium-based MRI was performed at baseline and 8 weeks later to evaluate infarct area and LV function. RESULTS: We enrolled 10 patients, age 63.8 +/- 2.8 years 5.2 +/- 4.12 x 10(6) MSC were infused via coronary artery 24.8 +/- 16 days after infarction. The procedures were successful in all patients without any in-hospital event. Infarct size by MRI decreased by 5.84% (P = .018) over 8 weeks. Mean baseline left ventricular ejection fraction (LVEF) was 44.1% +/- 9% and was 46.3% +/- 9% at 8 weeks (P = .34). A trend of smaller LV end-systolic volume with 65.02 +/- 18.2 ml vs 63.04 +/- 21.89 ml (P = .09) with no change of LV end-diastolic volume observed. CONCLUSION: MSC infusion into coronary circulation was feasible and safe after myocardial infarction. Infarct size was reduced with preservation of LV geometry.